Surgical Assistance Device

This application claims priority under 35 USC § 119 (e) to U.S. Provisional Application Ser. No. 63/649,980, entitled “Surgical Assistance Device”, filed May 21, 2024, the disclosure of which is incorporated by reference herein.

The present invention is generally directed to medical devices, and more specifically to an orthopedic surgical assistance device worn on a finger, for example, a surgeon's or other practitioner's forefinger and configured to orient a guidewire for insertion into a patient.

Mini-incisions are a standard of care, even in patients with elevated BMI (Body Mass Index), because research has shown that there is significantly less tissue trauma from surgery with smaller incisions. Benefits to the patient include less post-surgery pain, a shorter recovery period, and less scarring. In many situations, it can be technically challenging to achieve such benefits, especially in patients with robust hips, based on how difficult it is to achieve proper positioning to insert and drill surgical implants, for example, such as guidewires, including long drillable guidewires.

When a surgeon or other practitioner fixes, for example, a femur fracture, after making an appropriate incision, he or she palpates the bone by hand to locate an optimum location for inserting a guidewire into the bone. Once so located, the guidewire is then drilled into the bone. It is difficult to insert the guidewire at the desired location and at the desired orientation while keeping one hand on the patient's femur bone and using the other hand to operate the drill with the guidewire, especially when the amount of adipose tissue and muscle attached and covering the tip of the femur bone significantly affects the drilling angle of the guidewire into the bone. The guidewire can slip out of position and, for example, off the femur bone. Imaging equipment is needed to facilitate drilling, adding complexity. The surgeon's glove can be pierced or torn by the guidewire and/or due to the slippage. Currently there is a void of medical devices that function as intraoperative surgical assistants specifically designed for fracture care in injured patients.

One proposal to address this problem is disclosed in Chinese utility model CN211934259U. An auxiliary Kirschner wire imbedding device has a thumb ring and a finger ring that each have squeeze plates arranged thereon. Grooves in each squeeze plate align when the opposing faces of the plates are brought together by squeezing the thumb ring and finger ring toward one another, thereby to form a guide that holds the Kirschner wire in the aligned grooves between the squeeze plates. The proposed device is cumbersome due to the shape of the plates and the need for the clinician to have rings on both a finger and a thumb. The guidewire position is not maintained if gripping pressure is released between the finger and thumb. This device requires two fingers to hold the two pressing plates, one on the thumb and the other on the index finger and to squeeze pressing plates with a groove to help with Kirshner wire insertion. The proposed device is cumbersome due to the shape of the plates and requires the clinician to have two rings on one on a finger and the other on a thumb. This device is not intended to be used during surgery and does not fit inside a patient's mini-incision.

U.S. Pat. No. 8,142,416 B2 discloses a guide wire introducer with integrated wire steering function for treating bone. The guide wire employed with the introducer includes a bore material that is a pseudo-elastic metal alloy, such as Nitinol. This introducer has a chamfered tip with the complement of the outer construction including a uniform narrow outer diameter enabling insertion into soft tissue and bone with a guide wire therein. The chamfered tip of the introducer incorporates as integrated slit that enables the steering function of the introducer. Additionally, the outer surface of the introducer incorporates a radiolucent notch for radial position reference.

WO 2014/162459 A1 describes a medical aid having a mounting part which is mounted on a finger that wears a medical glove on top of the medical glove, and a picking part which is attached to the mounting part and extends toward a distal end along the finger from the mounting part. The length of the picking part in the lateral direction is greater than the thickness of the picking part. The thickness of the picking part tapers from the base end to the distal end. The medical aid is used when holding a wire-like medical tool. The picking part functions as an extension to the clinician's forefinger to facilitate picking up or scraping a wire.

Other finger-mounted surgical aids are addressed to different concerns that do not involve guidewires. For example, US 2004/0193211 A1 shows a minimally invasive surgical instrument that may be used in hand-assisted laparoscopic surgeries. The device is multifunctional surgical instrument that may be mounted directly on a surgeon's fingertip and inserted through an incision to allow the surgeon to manipulate tissue during a surgical procedure.

WO 2004/073495 A2 shows a surgical instrument that may be used in hand-assisted laparoscopic surgeries. The device is a multifunctional surgical instrument that may be mounted directly on a surgeon's fingertip and inserted through an incision to allow the surgeon to manipulate tissue during a surgical procedure.

U.S. Pat. No. 5,925,064 shows a series of surgical instruments mounted directly on a surgeon's fingertips in a way that the surgeon can insert his or her hand into a patient through a minimal incision to perform surgical procedures, and also to use his or her fingers to manipulate tissues. The invention enables the surgeon to perform the procedures with all the benefits of minimally invasive surgery, but with much greater tactile sense, control, and ease of manipulation, than enabled by known minimally invasive surgical instruments.

Improvements to aid surgeons or other clinicians to effectively locate and insert guidewires into desired locations of the bones of surgical patients continue to be sought. None of the aforementioned devices are approved or indicated for use in orthopedic surgery to assist with the intraoperative treatment of bone injuries.

A surgical assistance device has a substantially ring-shaped band (continuous or discontinuous) from which outwardly extends a first clasp jaw and a second clasp jaw. The first clasp jaw has a prong end and the second clasp jaw in one embodiment has two prong ends: a first prong end and a second prong end. In such embodiment, the first prong end and the second prong end are spaced apart. At least a portion of the first clasp jaw is configured to be received in the space between the first prong end and the second prong end of the second clasp jaw. When the first clasp jaw and the second clasp jaw are so engaged together a channel configured to receive a surgical guidewire is formed. One or more of the prong end of the first clasp jaw and the first prong end and the second prong end of the second clasp jaw are movable in relation to one another. Such movement permits the opposing prong ends to be separated or spaced apart a sufficient distance to create an opening in the channel so that the guidewire can be extracted from the channel.

In an advantageous embodiment of the surgical assistance device, the band defines an elongated slot, and a proximal portion of the first clasp jaw is swivelably or pivotably held in the elongated slot of the band. In this embodiment, the first prong end and the second prong end of the second clasp jaw have proximal ends extending from the band at opposite sides of the elongated slot.

In an especially advantageous embodiment of the surgical assistance device the first clasp jaw and/or the second clasp jaw swivel or pivot when opposing external circumferential surfaces of the band are squeezed. In this manner, the surgeon or other clinician may retain the band on their forefinger and squeeze opposing sides of the band to separate the prong ends of the first and second clasp jaws and thereby open the channel so that a guidewire may be extracted from the channel. In other words, the surgical assistance device may be extracted from the patient while the guidewire remains in the patient even without removing the band of the surgical assistance device from the surgeon's or clinician's finger.

The prong end of the first clasp jaw may opposingly face the first prong end and the second prong end of the second clasp jaw when said prong end and said first prong end and second prong end are separated from one another.

In one embodiment of the surgical assistance device the proximal ends of the first clasp jaw and the second clasp jaw extend substantially radially outwardly from the band. In such embodiment, the band defines a center axis, and the channel defines a channel center axis, with the channel center axis substantially parallel to the center axis of the band. With this embodiment, the threaded guidewire may be advanced in a direction that is substantially parallel to the surgeon's or other clinician's finger that is wearing the band.

The band, the first clasp jaw and the second clasp jaw may be integrally formed of a same material. In one embodiment, the surgical assistance device is formed of a metal or medical-grade plastic that can withstand medical sterilization at a temperature of about 270° F. or above. Representative metals are stainless steel, aluminum and alloys thereof.

In still another advantageous embodiment of the invention, a surgical assistance device has a substantially ring-shaped band. A first clasp jaw extends outwardly from the band and has a prong end. A second clasp jaw extends outwardly from the band and has a first prong end. The prong end of the first clasp jaw opposingly faces the first prong end of the second clasp jaw, with the first clasp jaw and the second clasp jaw when engaged together or in contact with one another forming a channel configured to receive a guidewire. One or more of the prong end of the first clasp jaw and the first prong end of the second clasp jaw are movable in relation to one another. Optionally, the band defines an elongated slot, and a proximal portion of the first clasp jaw is swivelably or pivotably held in the elongated slot of the band. In this embodiment, the band defines a center axis, and the channel defines a channel center axis, and the channel center axis is substantially parallel to the center axis of the band.

Just as with earlier embodiments, the band, the first clasp jaw and the second clasp jaw may be integrally formed of a same material. The surgical assistance can be formed of a metal that can withstand medical sterilization at a temperature of about 270° F. or above, such as but not limited to, stainless steel or aluminum or alloys thereof.

Another aspect of the invention is a method of placing and advancing a surgical guidewire. The steps of a method may include, for example, wearing a surgical assistance device according to the invention on a forefinger or gloved forefinger, with the first clasp jaw and the second clasp jaw engaged together. The method may further include the step of inserting the forefinger or gloved forefinger through an incision in a patient to determine by feel a desired location for guidewire insertion into a bone of the patient. Additionally, the method may include the step of threading the guidewire through the channel of the surgical assistance device and advancing the guidewire into the bone of the patient. Additionally, the method may include the steps of squeezing opposing sides of the band to swivel or pivot one or both of the first clasp jaw and the second clasp jaw to separate the prong of the first clasp jaw from the first prong and the second prong of the second clasp jaw to open the channel and detaching the channel from the guidewire.

In a variant of the inventive method, the prong end of the first clasp jaw opposingly faces the first prong end and the second prong end of the second clasp jaw when said prong end and said first prong end and second prong end are separated from one another.

It is envisioned that the proximal ends of the first clasp jaw and the second clasp jaw may extend substantially radially outwardly from the band. In this configuration, the band defines a center axis, wherein the channel defines a channel center axis, and the channel center axis is substantially parallel to the center axis of the band. The guidewire then may be threaded in the direction of the channel center axis, which is a direction substantially parallel to the forefinger of the surgeon or clinician wearing band of the surgical assistance device.

It should be appreciated that the present invention provides practitioners with a sense of feel and function by providing a targeted drill guide for the optimum starting point to expedite and facilitate orienting a guidewire for insertion into a patient, and more specifically a tip (such as the trochanteric entry point) of a patient's fractured bone. Additional objectives, advantages, features and application possibilities of the present invention ensue from the description below of an embodiment referring to the drawings. In this context, all the described and/or depicted features, either on their own or in any meaningful combination, constitute the subject matter of the present invention, also irrespective of their compilation in the claims or the claims to which they refer.

For clarity, it is to be understood that the word “proximal” when concerning orientation in the human body refers to a direction relatively closer to the center of the body than another part. The opposite of “proximal” is “distal”. For example, the proximal part of a femur bone is closer to a hip joint, and a distal end of the femur bone is closer to a knee joint. When referring to structure of the surgical assistance device, the word “proximal” refers to a position closer to the surgeon or clinician wearing the device and “distal”, which is opposite of “proximal”, refers to a position spaced farther from the surgeon or clinician wearing the device.

Certain terminology is used in the following description for convenience only and is not limiting. Unless specifically set forth herein, the terms “a,” “an” and “the” are not limited to one element, but instead should be read as meaning “at least one.” The terminology includes the words noted above, derivatives thereof and words of similar import.

It also should be understood that the terms “about,” “approximately,” “generally,” “substantially” and like terms, used herein when referring to a dimension or characteristic of a component of the invention, indicate that the described dimension/characteristic is not a strict boundary or parameter and does not exclude minor variations therefrom that are functionally similar. At a minimum, such references that include a numerical parameter would include variations that, using mathematical and industrial principles accepted in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.), would not vary the least significant digit.

The present invention will be described in detail by way of examples with reference to the attached drawings. Throughout this description, the preferred embodiments and examples shown should be considered as exemplars, rather than as limitations on the present invention. As used herein, the “present invention” refers to any one of the embodiments of the invention described herein, and any equivalents. Furthermore, reference to various feature(s) of the “present invention” throughout this document does not mean that all claimed embodiments or methods must include the referenced feature(s). The following description is provided to enable any person skilled in the art to make and use the invention and sets forth the best modes contemplated by the inventor of carrying out his invention. Various modifications, however, will remain readily apparent to those skilled in the art without departing from the spirit and scope of the invention, which is defined by the accompanying claims.

Referring now to the drawings, wherein the showings are for purposes of illustrating embodiments of the subject matter herein only and not for limiting the same,illustrates an embodiment of a surgical assistance device. The surgical assistance deviceis intended in one advantageous deployment to facilitate placement and orientation of a guidewire() into a patient's bone(e.g., a femur bone, as shown in) in an orthopedic surgery.

As shown in, the surgical assistance devicemay include a band(e.g., a finger band) sized to be worn on a finger(as shown in), for example, a surgeon's or other practitioner's or clinician's index finger. In some embodiments, as shown in, the bandmay be a substantially ring-shaped band. Additionally, or alternatively, the shape of the band(or portions thereof) may be oval, polygonal or another shape structure configured to be worn on the finger.

In some embodiments, the bandmay be sized to fit on one finger(i.e., the bandmay fixed and not adjustable). Additionally, or alternatively, the bandmay be adjustable to fit on any finger. In some embodiments, the adjustability of the bandmay result from the materials forming the band. For example, the bandmay be formed from a flexible material that allows for adjusting the bandwith minimal to no effort. As another alternative, a portion of the bandmay be expandable to adjust the ring size to fit on any finger. Additionally, or alternatively, the bandmay be formed from a stiff, yet deformable, material, which may be adjusted to fit on any finger. In some embodiments, the ring-shaped bandmay be discontinuous and have one or more gaps. In any embodiment, the surgical assistance devicemay be made of a material that may withstand multiple surgical instrument cleaning cycles, for example, at temperatures of 270° F. or above. For example, the material forming the surgical assistance devicemay be a metal, such as but not limited to, stainless steel or aluminum or alloys thereof.

With continued reference to, the surgical assistance deviceincludes at least one channelat an upper end of the band. The channelis shaped and sized for a guidewire() to be threaded (or inserted) therethrough and into a patient, for example, during a medical procedure.

In some embodiments, the bandand the channelmay be separate pieces operably connected to form the surgical assistance device(e.g., a unibody surgical assistance device). The materials forming the channelmay differ from the materials forming other parts of the surgical assistance device(e.g., the band). The materials forming two or more parts of the surgical assistance devicemay also be the same, as described in the exemplary embodiments herein.

Additionally, or alternatively, the surgical assistance devicemay include one or more gaps. In one embodiment, a surface of the bandand/or the channelmay be gapped (i.e., included a gap). A first gap in the bandmay be formed at a lower end of the bandopposite a surface where an upper part of the bandand lower part of the channelare contiguous. A second gap in the channelmay be formed at an upper part of the channelopposite the surface where the lower part of the channeland upper part of the bandare contiguous. In some embodiments, the first gap and the second gap may be aligned at opposite ends of the surgical assistance device. The first and second gap may have the same or different sizes. The first gap should be sized to retain the finger therebetween at least during operation (i.e., when the surgical assistance deviceis used). The second gap should be sized to retain the guidewirewithin the channelduring operation. In some embodiments, opposed ends at the upper part of the channel, where the second gap is formed, may be movable towards each other to reduce the channelopening for receiving the guidewireor away from each other to increase such opening. It should be appreciated that moving the opposed ends towards each other to touch or otherwise connect the opposed ends reduces or eliminates the gap (e.g., the first and/or second gap). An adjustable gap (e.g., the first gap and/or second gap) provides many benefits. For example, a single bandhaving a gap would accommodate fingers of different sizes. Adjusting the second gap (as described above) would allow for a single embodiment of the channelto accommodate guidewiresof different sizes (gauges).

With continued reference to the figures, and with reference now to, the channelmay be formed from the same material forming the band, such as a metal, or more preferably stainless steel or aluminum or an alloy thereof. As shown in, a first clasp jawand a second clasp jawextend substantially radially outwardly from the bandat a fulcrum. The first clasp jawhas its proximal end at the bandand has a curved prong endwith a distal tip. The second clasp jawcomprises a first prong endand a second prong endspaced apart from the first prong end. Each of the first prong endand the second prong endhave proximal ends at the bandand terminate at distal tips. The prong endof the first clasp jawfits between the first prong endand second prong endof the second clasp jawin the space between the first prong endand the second prong end. In an initial closed configuration, the prong endof the first clasp jawis fitted between the first prong endand second prong endof the second clasp jaw. In this closed configuration, the channelis formed between the first clasp jawand the second clasp jaw, which channelis sized to threadably receive the guidewireto be inserted into the patient.

It should be appreciated that in the embodiment shown in, the surgical assistance deviceis integrally formed from a strip of a same material that is cut to form the first clasp jawat one end and to form a slotand second clasp jawat the opposite end. The strip is then bent to form the curved finger band, the prong endand first and second prong ends,, and a base portion (proximal end portion) of the prong endof the first clasp jawis seated and held in the slotat the fulcrum. Other clasp mechanisms are envisioned, including but not limited to, lobster claw clasps or spring ring clasps known in the jewelry industry. Particularly if other clasp mechanisms are employed, the bandcould be formed of a different material from the clasp mechanism.

With continued reference to the figures, and with reference now tothrough, a method of using the surgical assistance deviceis illustrated schematically. A flowchart of a method of using the surgical assistance deviceis provided in.throughschematically illustrates installing a guidewire into the bone, for example, at the trochanteric entry point often used for fixation of femur factures.

As shown in the exemplary embodiment of, a surgeon or other clinician cuts a suitable incisionwith a scalpelto provide access to a patient's bone, such as a femur, into which a guidewirewill be installed as part of a fixation of a femur fracture. As shown in the exemplary embodiment of, the surgeon or other clinician wears the bandof the surgical assistance deviceon his or her finger, preferably the forefinger. The surgical assistance deviceis so worn as the surgeon or other clinician palpates the patient's bone through the surgical incisionto locate the desired entry point for installing the guidewire. The exemplary embodiment ofshows the guidewirethreaded into the channelbetween the first clasp jawand second clasp jaw.

The exemplary embodiment ofillustrates the drilling of the guidewireinto the patient's bonewhile the guidewireis threaded through the surgical assistance device. The surgeon or clinician may retain his or her fingerin contact with the patient's bonewhile threading and drilling the guidewireinto the patient's boneat the desired entry point. The surgical assistance deviceacts as a mechanical conduit for the guidewire, directing the guidewireat the desired entry point and in the desired orientation and direction during the surgical procedure. All the while, the surgeon or clinician may maintain his or her fingerin contact with the patient's bone. The surgical assistance devicemaintains the guidewirein a direction that is generally or substantially parallel to the fingeron which the bandis worn.

The prong endof the first clasp jawand the first and second prong ends,of the second clasp jaware movable at the fulcrumbetween them.andshow that the distal end of the prong endof the first clasp jawmay be spaced apart from the distal ends of the first prong endand second prong endsof the second clasp jawin response to squeezing force applied to the opposite outer circumferential surfaces of the band. The squeezing force may be so applied while the bandremains on the finger, for example, as shown in.

Additionally, or alternatively, the squeezing force may be so applied after the bandhas been removed from the finger, as shown in. Once the prong endsand,are sufficiently separated, the channelformed by the first clasp jawand second clasp jawmay be opened sufficiently to create a spaceto release the surgical assistance deviceaway from the guidewireand extract the surgical assistance deviceout of and/or away from the patient.

With continued reference to the figures, and with reference now to, an exemplary embodiment of a methodof performing a medical (e.g., a surgical) procedure using exemplary embodiments of the surgical assistance deviceto place and advance the guidewireis provided.

It should be noted that steps, recited below or in any claim, do not necessarily need to be performed in the order in which they are recited. Those of ordinary skill in the art will recognize variations in performing the steps from the order in which they are recited. In addition, the lack of mention or discussion of a feature, step or component provides the basis for claims where the absent feature or component is excluded by way of a proviso or similar claim language.

In step, the surgical assistance devicemay be worn on the finger(e.g., a forefinger or gloved forefinger) with the first clasp jawand the second clasp jawengaged together.

In step, the fingerwearing the surgical assistance devicemay be inserted through the incisionto determine by feel a desired location for guidewireinsertion into a boneof the patient.

In step, the guidewiremay be threaded through the channel of the surgical assistance deviceand advanced into the boneof the patient.

The methodmay further include in step, squeezing opposing sides of the bandto swivel or pivot one or both of the first clasp jawand/or the second clasp jawto separate the prong of the first clasp jawfrom the first prong and the second prong of the second clasp jawto open the channel, which may detach the channelfrom the guidewire.

In some embodiments, the prong endof the first clasp jawopposingly faces the first prong endand the second prong endof the second clasp jawwhen said prong endand said first prong endand second prong endmay be separated from one another. Additionally, or alternatively, the proximal ends of the first clasp jawand the second clasp jawmay extend substantially radially outwardly from the band. In this configuration, the banddefines a center axis, wherein the channeldefines a channel center axis, and the channel center axis is substantially parallel to the center axis of the band. The guidewirethen may be threaded in the direction of the channel center axis, which is a direction substantially parallel to the fingerof the surgeon or clinician wearing the bandof the surgical assistance device.